Perspectives in Clinical Research最新文献

{"title":"Designing and validating a research questionnaire - Part 2.","authors":"Priya Ranganathan, Carlo Caduff, Christopher M A Frampton","doi":"10.4103/picr.picr_318_23","DOIUrl":"10.4103/picr.picr_318_23","url":null,"abstract":"<p><p>Validity and reliability refer to the accuracy and consistency of a research tool. In the previous article in this series, we examined the development of a research questionnaire. In this article, we discuss the methods of determining the validity and reliability of a research questionnaire.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 1","pages":"42-45"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of therapeutic patient education program on glycemic control and quality of life among children and adolescents with type 1 diabetes mellitus in Fez city, Morocco.","authors":"Hanaâ Ait-Taleb Lahsen, Mohammed El Amine Ragala, Hanane El Abed, Btissame Zarrouq, Karima Halim","doi":"10.4103/picr.picr_80_23","DOIUrl":"10.4103/picr.picr_80_23","url":null,"abstract":"<p><strong>Context: </strong>Type 1 diabetes mellitus (T1DM) is a chronic disease, mainly observed in children or youth, with a significantly increased incidence in young children. Structured therapeutic patient education (TPE) is a must to help them manage their disease effectively and lead a healthy lifestyle.</p><p><strong>Aims: </strong>This study aimed to assess the effects of a structured TPE program on glycemic markers and quality of life (QOL) of T1DM children and adolescents in Fez city, Morocco.</p><p><strong>Settings and design: </strong>It is a quasi-experimental study.</p><p><strong>Materials and methods: </strong>One hundred T1DM children and adolescents, aged 8-18, participated in a TPE intervention at the pediatric department in a hospital center in Fez, Morocco. Glycemic markers were measured and QOL was assessed by a validated questionnaire.</p><p><strong>Statistical analysis used: </strong>Parametric and nonparametric tests were used and statistical significance determined by <i>P</i> < 0.05.</p><p><strong>Results: </strong>At 3 months' follow-up, both global and dimensional QOL mean scores improved significantly (<i>P</i> ≤ 0.0001), whereas glycosylated hemoglobin (HbA1c) decreased (10.28% vs. 10.62%), tough with no statistical significance (<i>P</i> = 0.160). Furthermore, a significant improvement was observed in the maximum preprandial (2, 11 g/L [1.51-2.58] vs. 2, 37 g/L [1.81-3.21], <i>P</i> = 0.001) and postprandial blood glucose levels (2, 50 g/L [1.90-3.27] vs. 2, 95 g/L [2.07-3.99], <i>P</i> = 0.001) after 3 months; with no significant change in their minimum.</p><p><strong>Conclusion: </strong>Although this TPE intervention was more effective in improving patients' QOL than their HbA1c, it is worth striving to implement regular TPE programs for T1DM pediatric patients and adjust them to achieve a better patients' glycemic markers levels.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 1","pages":"24-30"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139570723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial intelligence at the pen’s edge: Exploring the ethical quagmires in using artificial intelligence models like ChatGPT for assisted writing in biomedical research","authors":"Hunny Sharma, Manisha M Ruikar","doi":"10.4103/picr.picr_196_23","DOIUrl":"https://doi.org/10.4103/picr.picr_196_23","url":null,"abstract":"Chat generative pretrained transformer (ChatGPT) is a conversational language model powered by artificial intelligence (AI). It is a sophisticated language model that employs deep learning methods to generate human-like text outputs to inputs in the natural language. This narrative review aims to shed light on ethical concerns about using AI models like ChatGPT in writing assistance in the health care and medical domains. Currently, all the AI models like ChatGPT are in the infancy stage; there is a risk of inaccuracy of the generated content, lack of contextual understanding, dynamic knowledge gaps, limited discernment, lack of responsibility and accountability, issues of privacy, data security, transparency, and bias, lack of nuance, and originality. Other issues such as authorship, unintentional plagiarism, falsified and fabricated content, and the threat of being red-flagged as AI-generated content highlight the need for regulatory compliance, transparency, and disclosure. If the legitimate issues are proactively considered and addressed, the potential applications of AI models as writing assistance could be rewarding.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"391 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139171713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of factors that act as barriers in conducting academic trials – An investigator’s perception","authors":"S. Gajbhiye, G. Dakhale, C. Chindhalore, Ashish Vijay Gupta, E. T. Selvi","doi":"10.4103/picr.picr_76_23","DOIUrl":"https://doi.org/10.4103/picr.picr_76_23","url":null,"abstract":"Academic trials are essential in investigating health research questions relevant to the society. Only a few leading research institutions in India have been engaged in academic trials. Thus, there is a need to understand what factors dampen the spirit of the academician in conducting academic clinical trials. The aim of the study is to evaluate the investigator’s perception of obstacles to carrying out academic trials and to identify factors that will motivate investigators in conducting academic trials We conducted a prospective observational study in a tertiary care hospital for 6 months. Faculty members working in academic institutes were selected. A structured questionnaire was designed for the study and administered using google forms. Responses were taken on a Likert scale. Validity and reliability assessments were carried out. Mann-Whitney test was applied to assess differences between demographic groups. P <0.05 was considered significant. Most of the participants rated applying for research grants (76%), obtaining funding for the study and making arrangements for compensation for trial-related events (75%) as extremely challenging. We found that the degree of challenge is significantly lower in the faculty members who conducted clinical trials in the past as against those who did not (P = 0.00069). We also found that the degree of challenge is significantly higher in the faculty members with <10 years of experience than those with >10 years of experience (P = 0.00001). Thus, to conclude the challenges faced by investigators were at multiple levels, most common being applying for research grants and making arrangements for the funds for payment towards participation or study-related injury. Faculty members with exposure to conducting clinical trials and with experience of more than 10 years had perceived a reduced degree of challenges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"134 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139172315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An observational study to evaluate the awareness of drug treatment, prescription pattern, adverse drug reactions, and adherence in patients of major depressive disorder","authors":"U. Parmar, Pranali Puradkar, Kranti Kadam, Firoz M. Tadavi, Snehalata Gajbhiye, Shirish Joshi, Amitoj Sohal","doi":"10.4103/picr.picr_113_23","DOIUrl":"https://doi.org/10.4103/picr.picr_113_23","url":null,"abstract":"\u0000 \u0000 \u0000 Due to the paucity of studies in and out of India that dealt with treatment awareness of major depressive disorder (MDD), we decided to assess the awareness of MDD patients, and since adherence and awareness are linked to each other, we assessed adherence too. Prescription pattern studies identify changes in prescriptions due to poor initial response or adverse drug reactions (ADRs), which may result in dose reduction or switching medications and delay remission. Therefore, the study assessed the ADR pattern.\u0000 \u0000 \u0000 \u0000 A cross-sectional questionnaire-based study was carried out on 200 MDD patients with treatment records for at least 3 months after getting approval from the Institutional Ethics Committee and consent from the patients. The data obtained were entered in Microsoft Excel and analyzed using descriptive statistics.\u0000 \u0000 \u0000 \u0000 The mean age was 44.65 ± 12.02 years, and females were 70%. Maximum patients (98%) were aware of the consequence of stopping the drugs suddenly, and only 12.5% were aware of the onset of response to treatment. Escitalopram was the most common antidepressant prescribed (43.77%), and 67 ADRs out of 136 were attributable to it. Weakness and fatigue were the most common ADRs. The majority (97) of the ADRs were possibly related to antidepressants, and 65% of patients showed optimal adherence to medications.\u0000 \u0000 \u0000 \u0000 This study sheds light on the treatment awareness and adherence of MDD patients in India and highlights the need for educating patients about treatment response. It also emphasizes the importance of monitoring ADRs and adjusting prescription patterns accordingly to improve treatment outcomes.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"50 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138595496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home nursing in clinical trials: Result from semi-structured qualitative interviews","authors":"Pooja Sharma, S. Bhowmick, Kedar Nayak, Soma Bhattacharjee, Sandeep Lahiry","doi":"10.4103/picr.picr_218_22","DOIUrl":"https://doi.org/10.4103/picr.picr_218_22","url":null,"abstract":"\u0000 There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient’s home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"79 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138596031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends of different inflammatory markers and clinical outcomes in hospitalized COVID-19 patients","authors":"Srikanth Krishnamurthy, Nandagopal Velayuthaswamy, Jaymohan Unnithan, Nagarajan Srinivasan, Shobana Balasubramaniam, Ramesh Jagannathan","doi":"10.4103/picr.picr_123_23","DOIUrl":"https://doi.org/10.4103/picr.picr_123_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"33 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139273890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ChatGPT in medical writing: A game-changer or a gimmick?","authors":"Shital Sarah Ahaley, Ankita Pandey, Simran Kaur Juneja, Tanvi Suhane Gupta, Sujatha Vijayakumar","doi":"10.4103/picr.picr_167_23","DOIUrl":"https://doi.org/10.4103/picr.picr_167_23","url":null,"abstract":"OpenAI’s ChatGPT (Generative Pre-trained Transformer) is a chatbot that answers questions and performs writing tasks in a conversational tone. Within months of release, multiple sectors are contemplating the varied applications of this chatbot, including medicine, education, and research, all of which are involved in medical communication and scientific publishing. Medical writers and academics use several artificial intelligence (AI) tools and software for research, literature survey, data analyses, referencing, and writing. There are benefits of using different AI tools in medical writing. However, using chatbots for medical communications pose some major concerns such as potential inaccuracies, data bias, security, and ethical issues. Perceived incorrect notions also limit their use. Moreover, ChatGPT can also be challenging if used incorrectly and for irrelevant tasks. If used appropriately, ChatGPT will not only upgrade the knowledge of the medical writer but also save time and energy that could be directed toward more creative and analytical areas requiring expert skill sets. This review introduces chatbots, outlines the progress in ChatGPT research, elaborates the potential uses of ChatGPT in medical communications along with its challenges and limitations, and proposes future research perspectives. It aims to provide guidance for doctors, researchers, and medical writers on the uses of ChatGPT in medical communications.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139275181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research","authors":"R. Devarinti, M. S. Ganachari","doi":"10.4103/picr.picr_220_22","DOIUrl":"https://doi.org/10.4103/picr.picr_220_22","url":null,"abstract":"Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"3 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139272302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college","authors":"Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati","doi":"10.4103/picr.picr_88_23","DOIUrl":"https://doi.org/10.4103/picr.picr_88_23","url":null,"abstract":"The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}